Recruiting

Ultrasound Imaging

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04050423

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Our objective in this study is to identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize breast masses with high accuracy, as determined histopathologically. Breast cancer is the most frequent form of non-epithelial cancer diagnosed in women, with approximately 1.5 million new cases diagnosed annually worldwide. Accurate diagnosis and characterization of disease play an important role in therapy planning for breast cancer treatment. Currently, the gold standard method of tumour diagnosis is pathological examination of core biopsy specimens. However, the invasive core biopsies can cause post-surgical complications. Besides, some lesions require repeat biopsy due to sampling errors during the initial biopsy. Also X-ray mammography and ultrasound B-mode images, which are used by radiologists for breast examination, lack reliable information about micro-structural properties of tissues. There is an urgent need of a non-invasive imaging modality that can provide rapid and quantitative information for breast tumour characterization, in real time and at the patient bed. The main goal, as described above, is to select the best quantitative ultrasound parameters that can facilitate breast cancer characterization, non-invasively.

Conditions

Breast Cancer

Study ID

NCT04050423

Start date

Sep 23, 2014

Status verified date

Dec, 2023

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Women or men with suspected breast cancer
2. Patients should have the ability to understand and the willingness to sign a written Informed consent document.

Exclusion Criteria:

1. Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering in the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration
2. Receiving any other investigational agents
3. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Select the best quantitative ultrasound parameters that can facilitate breast cancer characterization, non-invasively [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Schontal Halstead

416-480-6100

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Gregory J Czarnota, Phd, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 14, 2023

Last verified

Dec, 2023

Keywords

  • Ultrasound
  • Spectroscopy
  • Characterization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-12-14.